Vivaxim

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Salmonella typhi Vi polysaccharide 25ug (Salmonella typhi Vi polysaccharide (Ty2 strain)); Hepatitis A virus formaldehyde inactivated, GBM strain 160 U

Available from:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (International Name):

Salmonella typhi Vi polysaccharide 25 µg (Salmonella typhi Vi polysaccharide (Ty2 strain))

Pharmaceutical form:

Solution for injection

Composition:

Active: Salmonella typhi Vi polysaccharide 25ug (Salmonella typhi Vi polysaccharide (Ty2 strain)) Excipient: Dibasic sodium phosphate dihydrate Monobasic sodium phosphate dihydrate Sodium chloride Water for injection Active: Hepatitis A virus formaldehyde inactivated, GBM strain 160 U Excipient: Aluminium hydroxide as aluminium Formaldehyde Medium 199 Phenoxyethanol as 2-phenoxyethanol solution 2.5µL

Units in package:

Syringe, glass, Dual chamber syringe, 1 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Sanofi Pasteur SA

Therapeutic indications:

VIVAXIM® is indicated for simultaneous active immunisation against typhoid fever and hepatitis A virus infections in subjects aged 16 and older.

Product summary:

Package - Contents - Shelf Life: Syringe, glass, Dual chamber syringe - 1 mL - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)

Authorization date:

2001-11-20

Patient Information leaflet

VIVAXIM
®
1
VIVAXIM
®
_Salmonella typhi Vi polysaccharide and inactivated hepatitis A virus
antigen vaccine _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about VIVAXIM.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines, including vaccines,
have risks and benefits. Your doctor
has weighed the risks of you having
VIVAXIM against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT THIS
VACCINE, ASK YOUR DOCTOR, NURSE OR
PHARMACIST.
KEEP THIS LEAFLET. YOU MAY NEED TO
READ IT AGAIN.
WHAT VIVAXIM IS USED
FOR
VIVAXIM is a vaccine used to help
prevent typhoid fever and hepatitis A
disease in adults aged 16 years and
older who are at risk of these
diseases.
_HOW IT WORKS _
VIVAXIM works by causing your
body to produce its own protection
against typhoid fever and hepatitis A
infection. It does this by making
substances called antibodies in the
blood, which fight the typhoid
bacteria and hepatitis A virus. If a
vaccinated person comes into contact
with the typhoid or hepatitis A
organisms, the body is usually ready
to destroy them.
Your body usually takes two weeks
after vaccination to develop
protection against typhoid fever and
hepatitis A infection.
Initial protection is provided by one
dose of VIVAXIM. For long-term
protection against hepatitis A virus a
booster vaccination with an
inactivated hepatitis A vaccine will
be required 6 to 36 months after
vaccination with VIVAXIM. The
body does not develop long-term
protection against typhoid fever and
repeat vaccinations are required to
maintain protection.
Most people will produce enough
antibodies against typhoid fever and
hepatitis A infection. However, as
with all vaccines, 100% protection
cannot be guaranteed.
The vaccine will not give you
typhoid fever or hepatitis A infection.
The chance of a severe reaction from
VIVAXIM is very small, but the
risks from not being vaccinated
against typhoid fever or hepati

Summary of Product characteristics

viv-ccdsv9-dsv3-20jun22
Page 1
NEW ZEALAND DATA SHEET
1
VIVAXIM SOLUTION FOR INJECTION
VIVAXIM
®
, Solution for injection
_Salmonella typhi_
Vi polysaccharide and hepatitis A virus
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Vivaxim contains a sterile suspension of purified Salmonella typhi Vi
polysaccharide and
formaldehyde inactivated hepatitis A virus antigen (GBM strain)
adsorbed onto aluminium
hydroxide. Vivaxim is presented in a dual-chamber by-pass syringe. The
contents of both
chambers are mixed immediately prior to injection by slowly pressing
the plunger.
Each 1.0 mL dose of mixed vaccine contains:
ACTIVE INGREDIENTS:
_Salmonella typhi_
Vi polysaccharide (Ty 2 strain)
25 micrograms
Hepatitis A virus*
160 antigen units**
*
GBM strain cultured on MRC-5 human diploid cells. MRC-5 is a cell line
that was
derived from human embryonic lung tissue in the 1960s.
**
In the absence of an international standardised reference, the antigen
content is
expressed using an in-house reference.
Contains phenylalanine. For the full list of excipients, see Section
6.1 List of excipients.
3
PHARMACEUTICAL FORM
The typhoid polysaccharide component is a clear and colourless
solution, the hepatitis A
component (inactivated, adsorbed) is a cloudy whitish suspension.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Vivaxim is indicated for simultaneous active immunisation against
typhoid fever and
hepatitis A virus infections in subjects aged 16 and older.
viv-ccdsv9-dsv3-20jun22
Page 2
4.2
DOSE AND METHOD OF ADMINISTRATION
The recommended dosage is 1 mL of the mixed vaccine. Vivaxim should be
administered by
slow intramuscular injection in the deltoid region. Vivaxim must not
be administered
intradermally or intravenously.
Primary immunisation is achieved with a single dose of Vivaxim.
The vaccine should be administered at least 14 days prior to risk of
exposure to both typhoid
fever and hepatitis A.
A single dose of Vivaxim does not ensure long-term protection against
infection with
hepatitis A virus. For long-term protection